FDA.reportPublic FDA data

PMA P130022S033

Device
Senza Spinal Cord Stimulation (SCS) System
Applicant
Nevro Corporation
PMA number
P130022
Supplement
S033
Product code
LGW
Decision date
2020-05-26
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Approval order statement
Approval for adding B1+RMS scanner limits to support 1.5T Full Body MRI conditional labeling for IPG1000/1500/2000/2500 with Surpass surgical and Percutaneous leads to enhance the safety of the Senza SCS system. Also, you requested approval for some other minor additional administration clarifications added in the manual based on customer feedback on the readability of the manual.

Current openFDA PMA Record#

Device
Senza Spinal Cord Stimulation (SCS) System
Applicant
Nevro Corporation
PMA number
P130022
Supplement
S033
Product code
LGW
Generic name
Stimulator, spinal-cord, totally implanted for pain relief
Decision date
2020-05-26
Decision code
APPR
Date received
2020-04-27
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for adding B1+RMS scanner limits to support 1.5T Full Body MRI conditional labeling for IPG1000/1500/2000/2500 with Surpass surgical and Percutaneous leads to enhance the safety of the Senza SCS system. Also, you requested approval for some other minor additional administration clarifications added in the manual based on customer feedback on the readability of the manual.